Sex Differences in Reflex Responses to Intermittent Hypoxia

Healthy Participants Clinical Trial

Official title:

Sex Differences in Reflex Responses to Intermittent Hypoxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606434
• Other study ID #: 2011312
• Secondary ID: 4R00HL130339
• Status: Completed
• Phase: N/A
• Start date: September 13, 2018
• Est. completion date: July 15, 2021

Study information

• Verified date: July 2021
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the present study is to determine whether there are sex differences in the reflex responses to hypoxia in humans.

Description:

Over 35% of the US population will develop sleep apnea at some point in their life. Sleep apnea is the most common form of sleep disordered breathing and patients with sleep apnea are at increased risk of developing high blood pressure. Intermittent, repeated exposures to low oxygen during sleep (intermittent hypoxia, IH) has been implicated as the primary stimulus for increases in sympathetic nervous system activity and blood pressure with sleep apnea. Interestingly there are some reports of a lower incidence of hypertension in women with sleep apnea when compared to men. Results from the present study will provide information important to the investigator's understanding of potential sex-differences in clinical outcomes for conditions related to acute/chronic hypoxia and may have important implications for treatments which may improve blood pressure control in patients with sleep apnea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• healthy adult men and women;
• BMI <30 kg/m2;
• non-pregnant;
• non-breastfeeding;
• non-smokers;
• premenopausal women with a normal menstrual cycle unaffected by hormonal contraceptive use;
• taking no medications known to affect autonomic or cardiovascular function (PI discretion).

Exclusion Criteria:

• taking any medications known to affect the cardiovascular or autonomic nervous system (e.g. alpha-blockers, beta-blockers, etc);
• a self-reported history of hepatic, renal, pulmonary, cardiovascular, or neurological diseases;
• stroke or neurovascular disease;
• bleeding/clotting disorder;
• sleep apnea or other sleep disorders;
• diabetes;
• smoking;
• history of alcoholism or substance abuse;
• hypertension.

Related Conditions & MeSH terms

• Healthy Participants
• Hypoxia

Intervention

Other:
• Hypoxic exposure
30 minutes of intermittent hypoxia

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Hypoxic Ventilatory Response after intermittent hypoxia	Hypoxia breathing will be recorded before and after intermittent hypoxia	Through completion of intermittent hypoxia, an average of 3 hours
Primary	Change from baseline Blood Pressure after intermittent hypoxia	Systolic and diastolic blood pressure will be recorded before and after intermittent hypoxia	Through completion of intermittent hypoxia, an average of 3 hours
Primary	Change from baseline Forearm Blood Flow after intermittent hypoxia	Blood flow in the forearm will be recorded before and after intermittent hypoxia	Through completion of intermittent hypoxia, an average of 3 hours